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Not Yet Recruiting NCT05711693

Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV)

Conditions: Hypertension, Aortic Aneurysm, Bicuspid Aortic Valve, Marfan Syndrome, Aortic Dilatation

Sex: All
Ages: 18 Years – 90 Years
Phase: NA
Enrollment: 100
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Summary

Aortic stiffness is an important imaging biomarker of vascular aging. The ascending aorta is the most elastic segment, and it is excluded by reference non-invasive method carotid to femoral pulse wave velocity (PWV). We propose to use laser-doppler vibrometry (LDV) to record superficial vibrations generated by cardiac activity and arterial pulses for measuring heart carotid PWV, a surrogate for ascending aorta.The trial aims to demonstrate the equivalence between heart-carotid PWV made by laser-doppler vibrometry (LDV) with the reference MRI measurement (4D-FLOW MRI).As secondary objectives, A) we aim to assess the reproducibility of LDV, compared with MRI, B) show that aortic stiffness measured by LDV fulfils international recommendations, C) to study the association between PWV and age or other cardiovascular risk factors, D) assess the acceptability of the measurement. For this, we include 100 consecutive patients, 50 women, 50 men, scheduled for clinically indicated thoracic aorta MRI.

Eligibility Criteria

Inclusion Criteria:Patients between 18 and 90 years of age in both sexes, who visit the hospital for MRI thoracic MRI as part of routine care.Enrolled in a social security plan or beneficiary of such a plan.Free, informed, written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any examination required by the research).and before any examination required by the research and even before the thoracic MRI planned in the care setting).Exclusion Criteria:Individuals under court protection, guardianship or under curator.MRI examination done in an emergency contextPatients with skin lesions (severe eczema, wounds, etc.) in the thorax or neck that do not allow the application of not allowing the application of the skin protection film on the area of interest;Allergies to the adhesive film.Patients who have a beard, which would make it difficult to apply an adhesive cast.Subjects who are not affiliated with social security or an equivalent plan.Refusal or linguistic or psychic incapacity to read the information and not object to the research.Patients with a serious pathology threatening the vital prognosis in the short and medium term (cancer metastatic cancer, end-stage renal failure, end-stage liver failure, end-stage heart failure) heart failure).Patients with a history of acute severe (II, IV) heart failure.Patients with progressive cardiovascular pathologies (unstable coronary artery disease, severe valvular disease,stroke, aortic dissection).Rhythm disorders: atrial fibrillation, high degree auriculoventricular block.Pregnant or breastfeeding womenPerson subject to an exclusion period for another research

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Source: ClinicalTrials.gov (NCT05711693). StuddyBuddy aggregates publicly available trial information.